Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

Sherif S. Farag

Status and phase: Terminated; Phase 2

Conditions: Chronic Myeloid Leukemia; Myelodysplasia; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Treatments: Drug: Fludarabine; Radiation: Total Body Irradiation; Drug: Palifermin; Biological: Rabbit ATG; Drug: Thiotepa

Study type: Interventional

Funder types: Other

Identifiers

NCT00593554

0704-19 IUCRO-0184

Details and patient eligibility

About

The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria

  • CR 1 with poor risk features
  • CR 2, or higher order CR

• Acute lymphoblastic leukemia (ALL) with one of the following criteria

  • CR 1 with poor risk features
  • CR 2, or higher order CR

• Myelodysplasia, RAEB I

• Donor has been identified

• Age ≤ 65 years.

• Performance Status 0-1.

Exclusion criteria

• Patients relapsing <6 months after autologous SCT are not eligible.
• Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
• Non-pregnant and non-nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

1

Active Comparator group

Description:

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Treatment:

Drug: Thiotepa

Biological: Rabbit ATG

Radiation: Total Body Irradiation

Drug: Fludarabine

2

Experimental group

Description:

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Treatment:

Drug: Thiotepa

Biological: Rabbit ATG

Drug: Palifermin

Radiation: Total Body Irradiation

Drug: Fludarabine